| CTRI Number |
CTRI/2019/08/020842 [Registered on: 22/08/2019] Trial Registered Prospectively |
| Last Modified On: |
22/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
clinical evaluation of siddha drug kukkilathi chooranam in excessive white discharge(leucorrhoea)patients of age group 18 to 60 |
|
Scientific Title of Study
|
phase II non randomized open clinical evaluation of siddha drug kukkilathi chooranam in kabayonirogam(vulvovaginal candidiasis)in female of age between 18 to 60 patients attending opd at AAGHIM attached with GSMC |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Bharathi |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college chennai |
| Address |
Post Graduate Department of General Medicine
Government siddha medical college
6 anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
Room no 2 pg ladies hostel
Goverment siddha medical college
6 anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9486147810 |
| Fax |
|
| Email |
sbharathi004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S M Chitra |
| Designation |
Lecturer |
| Affiliation |
Government siddha medical college chennai |
| Address |
Post Graduate Department of General Medicine
Government siddha medical college
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
6 Anna arch road
Goverment siddha medical college
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9444177230 |
| Fax |
|
| Email |
chittu758@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Bharathi |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college chennai |
| Address |
Post Graduate Department of General Medicine
Government siddha medical college
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
Room no 2 pg ladies hostel
Goverment siddha medical college
6 anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9486147810 |
| Fax |
|
| Email |
sbharathi004@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college |
| Address |
6 Anna arch road NSK nagar Arumbakkam Chennai Tamilnadu 600106 India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Bharathi |
Arignar Anna Government Hospital for Indian Medicine and homoeopathy |
No 2 department of general medicine
6 anna arch road
Nsk nagar
Arumbakkam
Chennai
TAMIL NADU |
9486147810
sbharathi004@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B373||Candidiasis of vulva and vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kukkilathi chooranam |
4 gms twice a day with ghee for 48 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
patients with the symptoms of whitish (curdy like) discharge vulvovaginal itching erosions inflammation surface is covered by whitish coat
known case of DM
positive candida albicans |
|
| ExclusionCriteria |
| Details |
Known case of sexually transmitted disease (Gonorrhea,Syphilis,HIV)
Known case of Nonspecific leucorrhea (Douches,Pessaries,tampons,trauma,drugs,chemicals)
Pregnancy and lactation
Known case of malignancy in uterus and ovary
Vulvovagainosis caused by other organism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| outcome is assessed by wet mount examination and clinical prognosis |
After 48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| outcome is assessed by comparing the safety parameters before and after treatment |
48 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Results will publish after completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a non randomized open clinical trial to evaluate the safety and efficacy of siddha trial drug kukkilathi chooranam in vulvo vaginal candidiasis patients of age between 18 to 60.clinical trial will be conducted after completion of preclinical trial study.All the collected data will be documented. |